Mixed Decisions on Lung Cancer Drugs

Peter Russell

July 08, 2019

A positive assessment by NICE on a tyrosine kinase inhibitor for lung cancer, and a promise by the Government to overhaul cancer screening programmes in England, are among the latest health announcements.

NSCLC

Adults with locally advanced or metastatic non-small cell lung cancer (NSCLC), that has tested positive for the epidermal growth factor receptor (EGFR) mutation, could be offered dacomitinib (Vizimpro, Pfizer), NICE said in draft guidance.

The decision overturns NICE's earlier appraisal that the tyrosine kinase inhibitor was not cost-effective.

It said clinical trial results showed that people who took dacomitinib survived for 34.1 months, compared with 26.8 months for those who took gefitinib (Iressa, AstraZeneca), a drug already recommended by NICE.

Dacomitinib also increased the length of time before the disease worsened, NICE said.

The manufacturer has a commercial arrangement which makes dacomitinib available to the NHS with a confidential discount to the list price of £2703 per pack of 30 capsules.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "Our committee acknowledged that dacomitinib had the potential to extend life for people with this type of lung cancer more than existing treatments currently available on the NHS.

"Responsible pricing by the company has allowed our committee to reconsider their initial decision. This has led to the positive recommendation announced today, allowing patients to benefit from this innovative treatment on the NHS."

The company estimated that around 1477 people would be eligible for this treatment each year.

'No' to Osimertinib

Separately, NICE rejected osimertinib (Tagrisso, AstraZeneca) for patients with the same condition on cost effectiveness grounds.

Appraisers accepted results from a randomised controlled trial that suggested people who took osimertinib lived longer than people who took erlotinib (Tarceva, Roche) or gefitinib, and that they lived longer before progression.

However, it said there was no direct evidence comparing osimertinib with afatinib (Giotrif, Boehringer Ingelheim), which might be more effective than erlotinib and gefitinib.

In the draft guidance, NICE also rejected osimertinib for inclusion in the Cancer Drugs Fund (CDF) on cost-effectiveness grounds.

Skin Cancer Drug for CDF

Hundreds of adult patients would be among the first in Europe to be able to access cemiplimab (Libtayo, Sanofi) for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (SCC) following a decision by NICE to include it in England's CDF.

An appraisal committee said despite significant uncertainty around the evidence for cemiplimab, the overall response rates reported in trials were promising. It decided that despite the drug's high cost, SCC was physically and emotionally challenging, and there was a high unmet need for new treatments.

The list price of cemiplimab is £80,877 per year, but the manufacturer agreed to provide the drug at a confidential discount.

John Stewart, NHS England's director of specialised commissioning, said: "NHS England has worked closely with Sanofi and NICE to reach a deal to make this hugely promising innovative drug available, meaning NHS patients in England will be among the first in Europe to benefit.

"Cemiplimab has the potential to make a significant impact for patients when previous treatments have failed, as aggressive surgery is often the only option."

Improvements Promised for Cancer Screening

Cancer screening programmes would be overhauled and diagnosis made faster and more accurate with new state-of-the-art technology, the Government promised this week.

Matt Hancock, Secretary of State for Health and Social Care, told the Commons how the NHS would deliver on commitments to improve early detection of cancer. It followed an ambition set out in the NHS Long Term Plan earlier this year for three-quarters of all cancers to be detected at an early stage, and 55,000 more people surviving cancer for 5 years each year by 2028.

Mr Hancock was speaking as the Implementation Framework was laid in Parliament. The blueprint for achieving the Government's ambitions at a local level include:

  • A radical overhaul of screening programmes

  • New state-of-the-art technology to make diagnosis faster and more accurate

  • More investment in research and innovation

  • The roll-out of new Rapid Diagnostic Centres across the country

  • An extension of lung checks by NHS England

  • An increase in the cancer workforce, leading to 400 clinical endoscopists and 300 reporting radiographers by 2021

Mr Hancock said: "Since 2010, cancer survival has improved year-on-year but, historically, our survival rates have lagged behind the best performing countries in Europe.

"In our Long Term Plan for the NHS, we set out a clear ambition to resolve this – and this framework sets out a step-by-step blueprint for local leaders to make that a reality."

Patient Safety Strategy

The first national NHS Patient Safety Strategy has been launched.

NHS Improvement said it set out a vision "for continuous safety improvement, underpinned by a safety culture and effective safety systems".

The strategy emphasised the need to support staff and look at systems rather than blaming individuals when incidents occurred.

Empowering patients and staff with the skills, confidence, and mechanisms to improve safety could save almost 1000 extra lives and £100 million in care costs each year from 2023-24, the document said.

Cluster Headache Treatment

A handheld device that delivers a small electric current was recommended by NICE for the prevention and treatment of cluster headaches.

In draft medtech guidance, it said that gammaCore (electroCore) could reduce the frequency and intensity of cluster headache attacks and improve quality of life.

The non-invasive vagus nerve stimulator, used in addition to standard care (sumatriptan, Imigran, GlaxoSmithKline - and others, zolmitriptan, generic, multiple suppliers and oxygen) could save the NHS £450 per patient in the first year compared with standard care alone, NICE said.

The guidance stressed that gammaCore was not effective in all patients with cluster headache but could benefit around a quarter of those who have the condition – around 25,000 people.

The technology was recently selected for the innovation and technology payment scheme, which was set up to accelerate the adoption and spread of proven and affordable innovations.

Dr Sam Roberts, chief executive of the Accelerated Access Collaborative, and director of innovation and life sciences for NHS England, said: "The health service has long been at the forefront of driving innovation, and as we start to deliver our ambitious long-term plan, we want the NHS to be a world leader in adopting life-changing innovations."

Storage and Transport Concerns Prompts Medicines Recall

Patients taking certain types of prescription-only medicines for Parkinson's disease, epilepsy, and blood clots were asked to check to see if they have products from batches of medicines that were subject to a recall.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the three products recalled at patient level were:

  • Clexane - enoxaparin (Clexane, Sanofi), rotigotine (Neupro, UCB Pharma), lacosamide (Vimpat, UCB Pharma)) 8000iu Injection 0.8ml

  • Neupro 4mg/24 hr patches

  • Vimpat 100mg tablets

The MHRA said the products had been parallel imported into the UK by B & S Healthcare from Italy and had been re-labelled in B & S Healthcare livery.

It said the effectiveness of the medicines could not be guaranteed due to uncertainties over storage and transport. However, it said the medicines were stable at room temperature and there was no evidence that they had been tampered with.

As a precaution, all other affected medicines were being recalled at pharmacy level, the MHRA said. These were:

  • Dovobet Gel - betamethasone dipropionate, calcipotriol monohydrate (Dovobet, Leo Laboratories)

  • Incruse Inhaler

  • Rosuvastatin (Crestor, AstraZenica) 10mg Tablets

  • Seebri Breezhaler - glycopyrronium bromide (Seebri Breezhaler, Novartis)

  • Spiriva Inhalation Powder

Seven Treatments Scrapped From Prescriptions

NHS England recommended seven items that should no longer be routinely prescribed in primary care.

The items were:

  • Aliskiren - aliskiren (Rasilez, Noden Pharma DAC)

  • Amiodarone (generic)

  • Dronedarone  - (Multaq, Sanofi)

  • Minocycline (generic)

  • Needles for pre-filled and reusable insulin pens for diabetes which cost more than £5 per 100 needles

  • Bath and shower emollient preparations

  • Silk garments

The recommendations followed a public consultation held between 28th November 2018 and 28th February 2019.

An initial recommendation that blood glucose testing strips that cost more than £10 for 50 strips should not be given to new patients was originally made in the consultation document. However, NHS England said further consideration would be given to the proposal after concerns were raised by patient groups that it could make it harder for individuals to manage their diabetes.

A spokesperson for NHS England and NHS Improvement commented: "During the consultation we heard a range of views from patients, clinicians, local commissioners and members of the public. The joint clinical working group also considered additional clinical evidence reviewed by the Specialist Pharmacy Service on the use of bath and shower preparations and silk garments for the treatment of dry and pruritic skin conditions.

"Based on the consultation findings we are undertaking further work to examine in more detail which factors influence the choice of blood glucose testing strips. The guidance therefore does not include proposals on the prescribing of blood glucose testing strips, at this stage."

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